An interventional study of Prolonged Exposure Therapy in Stress Disorders, Post-Traumatic and Substance Use Disorders, sponsored by Veterans Medical Research Foundation. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Veterans Medical Research Foundation · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are:
Posttraumatic stress disorder (PTSD) and substance use disorder (SUD) often co-occur. PTSD+SUD comorbidity is associated with more severe PTSD, worse treatment outcomes for substance use, greater suicide risk and worse functioning than having one of these disorders. First-line treatments for PTSD, particularly Prolonged Exposure Therapy (PE), are effective in treating PTSD among those with a SUD, and delivering these treatments concurrent to SUD programming is recommended by the VA/DoD Clinical Practice Guidelines. While PE is one of the most effective treatment options for PTSD among those with PTSD+SUD, effects are smaller and dropout is higher than among people with PTSD without a SUD. A promising way to enhance outcomes is to offer PE in a massed format (M-PE; i.e., multiple sessions per week instead of once weekly). M-PE has been shown to be effective in improving PTSD symptoms and substantially reducing dropout in military and Veteran populations. Preliminary findings suggest M-PE delivered concurrent to intensive SUD programming is a promising strategy that warrants further study. Evaluating the effectiveness of M- PE delivery in of SUD intensive outpatient programming (IOP) in improving PTSD and other mental health outcomes and reducing dropout as compared to weekly PE delivery (W-PE) is the necessary next step in this critical research.
The primary goal of this project is to determine if a promising way to treat PTSD among those with SUD, M-PE, will help Veterans with their PTSD symptoms and lead to better treatment completion rates more than PE delivered weekly and if the massed format will reduce substance use comparably to weekly PE among those in intensive SUD treatment. The study will also evaluate if M-PE helps Veterans function better and feel less depressed. M-PE is a one-on-one talk therapy that is delivered over twelve sessions several times a week. The therapy is brief because of the massed format so that it can be delivered at times when lengthy interventions may not be realistic, such as military mental health clinics on bases where military personnel may be getting ready to redeploy. The research team's preliminary work with Veterans in intensive SUD treatment showed M-PE to lead to improvements in PTSD and depression symptoms with no dropout, making this larger evaluation of M-PE compared to PE delivered in the traditional longer (weekly) format a critical next step. The study will accomplish this by randomly assigning participants who are in intensive SUD treatment to receive either M-PE or W-PE. The study will have 200 Veterans who served post 9/11 go through this study and the entire study is expected to take four years to complete. The study will run the study across four VAs (San Diego, Tampa, Chicago, and Atlanta).
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.
This study's planned enrollment of 200 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Veterans Medical Research Foundation is the lead sponsor of 43 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prolonged Exposure delivered in a massed format - sessions multiple times per week
Behavioral: Prolonged Exposure Therapy
Prolonged Exposure delivered with weekly sessions
Behavioral: Prolonged Exposure Therapy
Exposure therapy for PTSD
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity
Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
Time Line Follow back (TLFB)
Measures percent days of alcohol or other drug use, score range 0-100%, higher scores indicate greater percent days of use
Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
Psychotherapy Completion Rates
Percent of participants completing all sessions of psychotherapy, range is 0-100%, higher number means greater percent completed therapy
Time frame: 16 weeks
Patient Health Questionnaire-9 (PHQ-9)
Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity
Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
Brief Psychosocial Functioning Inventory (B-IPF)
Measures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment
Time frame: At 4-, 16-, 28-, and 40-weeks post-first therapy session
Client Satisfaction Questionnaire-8 (CSQ-8)
Measures satisfaction with treatment, scores range from 8 to 32. higher scores indicate greater satisfaction with treatment
Time frame: 16 weeks
Plan to share: Yes — Will share data with Strong Star Repository.
Supporting information: Study protocol
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Veterans Medical Research Foundation